Gaviscon® vs. omeprazole in symptomatic treatment of moderate gastroesophageal reflux. a direct comparative randomised trial
- Equal contributors
1 Département de Médecine Générale, Université François Rabelais, Faculté de Médecine, 10, boulevard Tonnellé, BP 3223,6, rue du Docteur Lebel 94300, Vincennes 37032, Tours Cedex 1, France
2 CHU de Nancy, Hôpital de Brabois, rue du Morvan, 54500 Vandœuvre-lès-Nancy, France
3 General Practice, 37800 Saint-Epain, France
4 Mediscan, 20, rue Saint-Saëns, 75015 Paris, France
5 Reckitt Benckiser Healthcare France, 15, rue Ampère, 91748 Massy Cedex, France
6 Reckitt Benckiser Group plc, 103-105 Bath Road, Slough, Berkshire SL1 3UH, UK
BMC Gastroenterology 2012, 12:18 doi:10.1186/1471-230X-12-18Published: 23 February 2012
Medical management of GERD mainly uses proton pump inhibitors. Alginates also have proven efficacy. The aim of this trial was to compare short-term efficacy of an alginate (Gaviscon®, 4 × 10 mL/day) and omeprazole (20 mg/day) on GERD symptoms in general practice.
A 14-day multicentre randomised double-blind double-dummy non-inferiority trial compared Gaviscon® (4 × 10 mL/day) and omeprazole (20 mg/day) in patients with 2-6 day heartburn episodes weekly without alarm signals. The primary outcome was the mean time to onset of the first 24-h heartburn-free period after initial dosing. Secondary outcomes were the proportion of patients without heartburn by D7, pain relief by D7, and reduction in pain intensity by D7 and D14.
278 patients were recruited; 120 were included in the Gaviscon® group and 121 in the omeprazole group for the per protocol non-inferiority analysis. The mean time to onset of the first 24-h heartburn-free period after initial dosing was 2.0 (± 2.2) days for Gaviscon® and 2.0 (± 2.3) days for omeprazole (p = 0.93); mean intergroup difference was 0.01 ± 1.55 days (95% CI = -0.41 to 0.43): i.e., less than the lower limit of the 95% CI of -0.5 days predetermined to demonstrate non-inferiority. The mean number of heartburn-free days by D7 was significantly greater in the omeprazole group: 3.7 ± 2.3 days vs. 3.1 ± 2.1 (p = 0.02). On D7, overall quality of pain relief was slightly in favour of omeprazole (p = 0.049). There was no significant difference in the reduction in pain intensity between groups by D7 (p = 0.11) or D14 (p = 0.08). Tolerance and safety were good and comparable in both groups.
Gaviscon® was non-inferior to omeprazole in achieving a 24-h heartburn-free period in moderate episodic heartburn, and is a relevant effective alternative treatment in moderate GERD in primary care.